The RxPONDER trial prospectively randomized 5083 HR+, HER2-, node-positive patients with Recurrence Score® results 0 to 25 to receive chemotherapy followed by endocrine therapy or endocrine therapy alone. Primary endpoints are to:15
- Assess the chemotherapy benefit for these patients according to their Recurrence Score result
- Determine if Recurrence Score results and chemotherapy are independently prognostic
RxPONDER study design: node-positive (1-3 nodes) patients with Recurrence Score results 0-25 were randomized to endocrine therapy alone or chemoendocrine therapy
First results from the study, led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI) indicate:16
- The majority of HR+, HER2-, N1, postmenopausal patients can be spared chemotherapy when decisions are guided with the Oncotype DX test
- Postmenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 can forgo adjuvant chemotherapy regardless of clinical pathological parameters
- Premenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 modestly benefit from chemotherapy
Safely spare postmenopausal patients chemotherapy with confidence16
Postmenopausal women with Recurrence Score result of 0-25 did not show benefit of chemotherapy in addition to endocrine therapy (competing risk-adjusted HR = 1.12, 95% CI 0.82-1.52, P=0.49). Consistent lack of chemotherapy benefit was observed for IDFS for subgroups of age, tumor size, grade, Recurrence Score result, and number of positive lymph nodes.
Determine chemotherapy options for N1 premenopausal patients with precision17
Premenopausal women with Recurrence Score result of 0-25 had a significant benefit in DRFI from the addition of chemotherapy to endocrine therapy (competing risk-adjusted HR 0.64, 95% CI 0.43-0.95, P=0.026). Consistent benefit of chemotherapy was observed for IDFS for subgroups of age, tumor size, Recurrence Score result, and number of positive lymph nodes. The 5-year absolute benefit of chemotherapy for distant recurrence was 2.4% (RS 0-13: 2.3%; RS 14-25: 2.8%).